FDA Radiology AI Devices

Ezra Flash is a software tool that uses AI (convolutional neural networks) to enhance brain MRI images by reducing noise. It supports 3-Tesla Siemens and GE MRI scanners for specific sequences, providing clearer images to assist radiologists in diagnosis without altering the original images.

Ultrasound System 2300 is a mobile, software-controlled diagnostic ultrasound system designed for a wide range of clinical applications including fetal, abdominal, pediatric, neuro, cardiac, and musculoskeletal imaging among others. It supports multiple ultrasound modes such as B-Mode, Doppler, Elastography, and Contrast Imaging to assist qualified healthcare professionals in imaging and guiding puncture and biopsy procedures, thereby improving diagnostic confidence and procedural accuracy.

RayStation 12A by RaySearch Laboratories is a comprehensive radiation therapy treatment planning system that allows users to import patient images, define treatment targets, optimize and evaluate radiation treatment plans, and administer them. It supports multiple imaging modalities including CT, PET, and MR, enhancing precision in oncologic care by helping clinicians design effective and tailored radiation treatments while ensuring safety and accuracy.

BoneMRI v1.6 is an AI-powered software that enhances MRI images to improve visualization of bone structures in the pelvic and lumbar spine regions. It uses advanced algorithms, including convolutional neural networks, to generate 3D images with enhanced bone contrast. This allows clinicians such as radiologists and orthopedic surgeons to better assess bone morphology and tissue density without the need for CT scans, improving diagnostic capabilities in these regions.

AIBOLIT 3D+ is a web-based software system that processes CT and MR medical images to create detailed 2D and 3D visualizations of anatomical structures. It assists healthcare professionals in surgical planning, training, and intraoperative reference by turning multi-dimensional images into easy-to-view and manipulate anatomical models, with color-coded organ identification to improve clinical decision-making.

BoneMRI v1.4 is an image processing software that analyzes 3D gradient echo MRI scans to enhance visualization of bone structures in the pelvic and lumbar spine regions. It uses a convolutional neural network algorithm to generate images with improved bone contrast compared to surrounding soft tissue, helping clinicians better assess bone morphology and density without the need for CT scans. It is intended for use by radiologists and orthopedic surgeons to aid in image interpretation, but not for tumor diagnosis.

MI View&GO is a software application developed by Siemens for medical professionals to review, manipulate, and analyze medical images from modalities like PET, SPECT, CT, and MRI. It integrates molecular imaging with anatomical data to support disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy planning. The software enhances image processing efficiency directly at the scanner console, allowing for timely quality assessment and basic reading of images.

EchoPAC Software Only / EchoPAC Plug-in is a software platform designed for diagnostic review, analysis, and reporting of ultrasound images. It allows post-processing of raw data from GE ultrasound scanners and DICOM ultrasound images, supporting multiple clinical applications like fetal, cardiac, abdominal, and musculoskeletal imaging. The software helps clinicians manage patient records and generate detailed reports efficiently.

SwiftMR is a software device that automatically enhances MRI images by reducing noise and increasing image sharpness using deep learning algorithms. It supports brain, spine, and musculoskeletal MRI images and integrates with existing PACS systems to improve diagnostic image quality without interrupting clinical workflow.

MRCAT Head & Neck is a software tool integrated into Philips MR systems that automatically processes MRI data to create synthetic CT-like images for radiation therapy treatment planning in patients with soft tissue tumors in the head and neck region. It helps clinicians accurately estimate radiation dose distributions without needing a separate CT scan, improving planning precision and patient care.